BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
FDA 510(k) clearance K040940 · decided 2004-04-19
Clearance details
- K-number
- K040940
- Device name
- BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
- Applicant
- Olympus Corporation
- Decision
- Substantially Equivalent
- Date received
- 2004-04-12
- Decision date
- 2004-04-19
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Melville, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by Sybron recall (Z-0917-2010) | Sybron Dental Specialties | 2010-03-02 |